Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

MIND (Management of Traumatic Brain Injury Diagnosis) (MIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02262286
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Diagnostics Division

Brief Summary:
Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.

Condition or disease
Brain Injury

Layout table for study information
Study Type : Observational
Actual Enrollment : 239 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions
Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Brain Injury
Brain Injury
Control
Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma



Primary Outcome Measures :
  1. Measurement of specific biomarker(s) for brain injury [ Time Frame: 48 hours ]
    Measurement of specific biomarkers to detect brain injury (mild to severe). using 2 or more serial draws from subjects. The biomarkers tested will include established biomarkers s100B, GFAP (Glial Fibrillary Acidic Protein) and also proprietary novel protein and lipid biomarkers that are being studied in discovery research.


Biospecimen Retention:   Samples Without DNA
Plasma and serum samples stored at -70C or colder


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals presenting to the ED within 6 hours of experiencing a head trauma, or bone fractions only.
Criteria

Inclusion Criteria:

  • Informed Consent Form Signed
  • 18 years of age or older
  • For women of child-bearing age: Not known to be pregnant AND
  • Head Trauma within 6 hours of ED presentation with Glasgow Coma Scores from 3-8 (Severe Injury), 9-13 (Moderate Injury), or 14-15 (Mild Injury); OR
  • Head trauma within 6 hours of ED presentation with Glasgow Coma Score of 15; OR
  • Bone fracture or poly-traumas, both with no head trauma

Exclusion Criteria:

  • Known pre-existing neurological condition that causes observed symptoms
  • Recent history of head injury or seizures (within 1 year of current ED presentation)
  • Prisoner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262286


Locations
Layout table for location information
Germany
Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Abbott Diagnostics Division
Investigators
Layout table for investigator information
Principal Investigator: Peter Biberthaler, MD/PHD Klinikum reichs der Isar

Layout table for additonal information
Responsible Party: Abbott Diagnostics Division
ClinicalTrials.gov Identifier: NCT02262286     History of Changes
Other Study ID Numbers: 9GP-02-10DELK14
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Abbott Diagnostics Division:
Brain Injury

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System